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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Objective of study:
bioaccessibility (or bioavailability)
toxicokinetics
Test guideline
Qualifier:
according to guideline
Guideline:
other: US Food and Drug Administration Redbook II Guidelines (FDA, 1993).
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Taurine
EC Number:
203-483-8
EC Name:
Taurine
Cas Number:
107-35-7
Molecular formula:
C2H7NO3S
IUPAC Name:
2-aminoethanesulfonic acid

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
deionised
Duration and frequency of treatment / exposure:
90 days once daily
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (actual dose received)
Dose / conc.:
300 mg/kg bw/day (actual dose received)
Dose / conc.:
600 mg/kg bw/day (actual dose received)
Dose / conc.:
1 000 mg/kg bw/day (actual dose received)
No. of animals per sex per dose / concentration:
treated animals: 12
contols: 6
Control animals:
yes, concurrent vehicle
Details on dosing and sampling:
TOXICOKINETIC / PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled (delete / add / specify): blood
- Time and frequency of sampling: Blood samples taken from 3 animals/sex/dose, at time 0 (immediately prior to dosing), 1, 2, 4, 8 and 24 hours following dosing on days 0 and 90 of the study for estimation of plasma taurine levels. Blood samples were collected from concurrent controls (6 animals/sex) on the same days at 0, 2 and 8 hours following dosing with vehicle.

Results and discussion

Toxicokinetic / pharmacokinetic studies

Toxicokinetic parametersopen allclose all
Key result
Test no.:
#1
Toxicokinetic parameters:
Cmax: at around 1 hour after dosing
Key result
Test no.:
#1
Toxicokinetic parameters:
other: Generally returning to baseline values by 24 hours. Plasma concentrations 24 hours after dosing were comparable with control values both on study day 0 and on day 90.
Key result
Test no.:
#1
Toxicokinetic parameters:
half-life 1st: less than 1 hour
Remarks:
initial half life
Key result
Test no.:
#1
Toxicokinetic parameters:
half-life 2nd: Plasma taurine levels 2 hours after dosing were 21-51% of the values measured at one hour.
Key result
Test no.:
#1
Toxicokinetic parameters:
half-life 3rd: ranged from 8.7 to 40 hours.
Remarks:
terminal half-life
Key result
Test no.:
#1
Toxicokinetic parameters:
AUC: Values were similar on study days 0 and 90.

Metabolite characterisation studies

Metabolites identified:
not specified

Applicant's summary and conclusion

Conclusions:
In the toxicokinetic study, plasma taurine levels increased in a dose-related manner, reaching peak Cmax values at around 1 hour after dosing and generally returning to baseline values by 24 hours.
Plasma taurine levels 2 hours after dosing were 21-51% of the values measured at one hour. Initial half-life was less than 1 hour and terminal half-life ranged from 8.7 to 40 hours.
Plasma concentrations 24 hours after dosing were comparable with control values both on study day 0 and on day 90. Area under the plasma-time concentration curve (AUC) values were similar on study days 0 and 90.
Both Cmax and AUC were proportional to dose. This study showed that taurine is readily bioavailable following oral administration and that it does not accumulate.